Cleared Traditional

K151185 - AGRX Wound Wash Antibacterial Silver Sk...

K151185 · Abl Medical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
277d
Days
-
Risk

K151185 is an FDA 510(k) clearance for the AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wou.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Abl Medical, LLC (American Fork, US). The FDA issued a Cleared decision on February 5, 2016 after a review of 277 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Abl Medical, LLC devices

FDA 510(k) Submission Details - K151185

510(k) Number K151185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2015
Decision Date February 05, 2016
Days to Decision 277 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 115d · This submission: 277d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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